Tebipenem Pivoxil Tablet Formulation: First Approval
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1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. cdi@adis.com.
Abstract:
Tebipenem pivoxil is an orally available carbapenem prodrug with antibacterial activity against a range of Gram-negative and some Gram-positive bacterial pathogens. A fine granule formulation of tebipenem pivoxil (Orapenem®) was approved in Japan in 2009 and is indicated for use in the treatment of pneumonia, otitis media and sinusitis in paediatric patients. More recently, Spero Therapeutics in collaboration with GSK has developed a high-drug-content tebipenem pivoxil tablet formulation (UTEBZI), containing the hydrobromide salt of tebipenem pivoxil, for oral administration. In June 2026, the tebipenem pivoxil tablet formulation received its first approval, in the USA, where it is indicated for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain specified susceptible pathogens in adult patients who have limited or no alternative oral treatment options. This article summarises the milestones in the development of the tebipenem pivoxil tablet formulation leading to this first approval for the treatment of cUTIs, including pyelonephritis, in adults.
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